Do we potentially have a case against the FDA for failing to fast track us as it approves other drugs with questionable success rates? https://www.biospace.com/article/6-drugs-approved-despite-failed-trials-or-minimal-data-/?s=74 I believe Vanda currently has an open case against the FDA for a denial of fast track. In my opinion failure to pass judgement is non-approval when you have satisfied what is required for consideration. https://www.bloomberglaw.com/public/desktop/document/VANDAPHARMACEUTICALSINCvFOODANDDRUGADMINISTRATIONetalDocketNo122c?doc_id=X26T5V243949RK895SH4KFQU9TC